Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were healthy adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine Unadjuvanted

Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

15 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

15 mcg H1N1 Vaccine Unadjuvanted

Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine Unadjuvanted

Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

15 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

15 mcg H1N1 Vaccine Unadjuvanted

Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 8 after the first vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 8 after the first vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8 after the second vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 180 after the second vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 270 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 180 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 270 after the second vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]